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临床试验/NCT02714777
NCT02714777已完成不适用

General Anesthesia and Autonomic Nervous System in Children

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Description of parasympathetic activity evolution by heart rate variability

研究概览

简要总结

The objective of the ANESPEDIA study is to describe in a pediatric population (aged from 4 to 8 years old) receiving elective surgery, the impact of general anesthesia on autonomic nervous system and their kinetics of early postoperative course (24 hours).

详细描述

Some physiological factors such as sport activity or pathological as sepsis, certain chronic diseases or diabetes are known to modulate the overall autonomic activity and the intrinsic capacity of the individual to regulate its sympathovagal balance. These influences can alter the physiological autonomic balance sometimes with positive consequences on the Cardiac frequency-breathing control, blood pressure adjustment depending on the position of the individual, on the status of blood volume, but sometimes deleterious with bad regulation of sinus cardiac activity and respiration rate.

General anesthesia is recognized as one of the factors that can modify more or less sustainable the sympathovagal autonomic balance. While many studies described the effects of anesthesia on the autonomic nervous system, most data are done in adult subjects. For the child who sees intrinsically autonomic physiological changes related to its maturative status, assessment of the impact of anesthesia in the pediatric population in per and postoperative was never realized.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Post-anesthesia Monitoring in pediatric intensive care units or Pediatric Surgery Hospital North of Saint Etienne.
  • Compendium of the form signed by the holder of parental authority

排除标准

  • Child with pathologies reaching the central nervous system or the brain stem.
  • Children with a severe pathology of cardio-respiratory or heart being referred to treatment.
  • Children requiring emergency surgery or trauma or septic or inflammatory context

结局指标

主要结局

Description of parasympathetic activity evolution by heart rate variability

时间窗: 24 hours

Parasympathetic activity evolution will be described by heart rate variability

次要结局

  • Heart rate variability (HRV)(at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24 Hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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